PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial (POINT)

• ClinicalTrials.gov Identifier: NCT02374060
• Recruitment Status: Completed
• First Posted: February 27, 2015
• Results First Posted: November 5, 2018
• Last Update Posted: December 4, 2018
• Sponsor: JHSPH Center for Clinical Trials
• Collaborator: National Eye Institute (NEI)
• Information provided by (Responsible Party): JHSPH Center for Clinical Trials

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Macular Edema; Uveitis
• Interventions: Drug: Periocular triamcinolone 40 mg; Drug: Intravitreal triamcinolone 4 mg; Drug: Dexamethasone intravitreal implant
• Enrollment: 192

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Period Title: Overall Study
Started	65	63	64
Completed	63	62	61
Not Completed	2	1	3

Baseline Characteristics

Arm/Group Title		Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant	Total
Arm/Group Description		Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.	Total of all reporting groups
Overall Number of Baseline Participants		65	63	64	192
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with macular edema		74	82	79	235
Baseline Analysis Population Description		All eyes with uveitic macular edema at randomization according to assigned treatment ("as randomized")
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	65 participants	63 participants	64 participants	192 participants
		55; (22 to 87)	56; (18 to 86)	55; (19 to 85)	55; (18 to 87)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	65 participants	63 participants	64 participants	192 participants
	Female	39 60.0%	40 63.5%	40 62.5%	119 62.0%
	Male	26 40.0%	23 36.5%	24 37.5%	73 38.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	65 participants	63 participants	64 participants	192 participants
	White	46 70.8%	37 58.7%	39 60.9%	122 63.5%
	Hispanic	1 1.5%	3 4.8%	5 7.8%	9 4.7%
	Black	11 16.9%	19 30.2%	17 26.6%	47 24.5%
	Other	7 10.8%	4 6.3%	3 4.7%	14 7.3%
Intraocular pressure; Median (Full Range); Unit of measure: Mm Hg
	Number Analyzed	74 Eyes with macular edema	82 Eyes with macular edema	79 Eyes with macular edema	235 Eyes with macular edema
		14; (6 to 22)	14; (7 to 21)	13; (6 to 20)	14; (6 to 22)
Visual acuity [1]; Median (Full Range); Unit of measure: Standard letters
	Number Analyzed	74 Eyes with macular edema	82 Eyes with macular edema	79 Eyes with macular edema	235 Eyes with macular edema
		68; (25 to 91)	63; (13 to 88)	64; (23 to 86)	64; (13 to 91)
		[1] Measure Description: Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Retinal thickness at the center subfield; Median (Full Range); Unit of measure: Um
	Number Analyzed	74 Eyes with macular edema	82 Eyes with macular edema	79 Eyes with macular edema	235 Eyes with macular edema
		438; (278 to 922)	485; (236 to 824)	449; (243 to 1300)	462; (236 to 1300)
Concomitant systemic medication; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	65 participants	63 participants	64 participants	192 participants
		24 36.9%	23 36.5%	23 35.9%	70 36.5%

Outcome Measures

1. Primary Outcome

Title	Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
Description	The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better. The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickness was evaluated using masked assessments of OCT images.
Time Frame	At baseline and 8 weeks

Outcome Measure Data

Analysis Population Description

All eyes with uveitic macular edema at randomization according to assigned treatment ("as randomized")

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Mean (99.87% Confidence Interval); Unit of Measure: proportion of baseline retinal thickness
	.77; (.67 to .89)	.61; (.53 to .70)	.54; (.46 to .63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of the proportion of BL
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 99.87%; .65 to .96
	Estimation Comments	Ratio of intravitreal over periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of the proportion of BL
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 99.87%; 0.56 to 0.86
	Estimation Comments	ratio of dexamethasone over periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	The non inferiority margin was 1.16
Method of Estimation	Estimation Parameter	Ratio of the proportion of BL
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 99.87%; .71 to 1.08
	Estimation Comments	A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal

2. Secondary Outcome

Title	Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
Description	The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images.
Time Frame	At baseline and the 24 week visit

Outcome Measure Data

Analysis Population Description

All eyes with uveitic macular edema at randomization according to assigned treatment ("as randomized")

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Mean (99.87% Confidence Interval); Unit of Measure: proportion of baseline retinal thickness
	0.68; (0.59 to 0.79)	0.64; (0.56 to 0.74)	0.61; (0.52 to 0.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.35
	Comments	Two sided type I error threshold was 0.00132 since recruitment was halted after the single Two sided type I error threshold was 0.00132 since recruitment was halted after the single preplanned interim analysis
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of the proportion of BL
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 99.87%; 0.77 to 1.16
	Estimation Comments	Ratio of intravitreal over periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.07
	Comments	the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio of the proportion of BL
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 99.87%; 0.72 to 1.10
	Estimation Comments	ratio of dexamethasone over periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	The non inferiority margin was 1.16
Method of Estimation	Estimation Parameter	Ratio of the proportion of BL
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 99.87%; 0.77 to 1.16
	Estimation Comments	A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal

3. Secondary Outcome

Title	Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
Description	Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks.
Time Frame	Over 8 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Proportion of eyes
	0.41; (0.29 to 0.52)	0.79; (0.70 to 0.88)	0.84; (0.74 to 0.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.39
	Confidence Interval	(2-Sided) 95%; 0.24 to 0.53
	Estimation Comments	Intravitreal - periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; 0.29 to 0.59
	Estimation Comments	Dexamethasone - periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.45
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; -0.09 to 0.19
	Estimation Comments	Dexamethasone - intravitreal

4. Secondary Outcome

Title	Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
Description	Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks
Time Frame	Over 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Proportion of eyes
	0.61; (0.50 to 0.72)	0.73; (0.63 to 0.83)	0.74; (0.61 to 0.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.10
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.27
	Estimation Comments	Intravitreal - Periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.11
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.28
	Estimation Comments	Dexamethasone - Periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.98
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.002
	Confidence Interval	(2-Sided) 95%; -0.16 to 0.16
	Estimation Comments	Dexamethasone - Intravitreal

5. Secondary Outcome

Title	Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
Description	Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema.
Time Frame	Over 8 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Proportion of eyes
	0.20; (0.12 to 0.30)	0.47; (0.34 to 0.60)	0.61; (0.48 to 0.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0005
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.27
	Confidence Interval	(2-Sided) 95%; 0.11 to 0.43
	Estimation Comments	Intravitreal - periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95%; 0.25 to 0.56
	Estimation Comments	Dexamethasone - periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.12
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; -0.04 to 0.30
	Estimation Comments	Dexamethasone - intravitreal

6. Secondary Outcome

Title	Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
Description	Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks.
Time Frame	Over 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Proportion of eyes
	0.35; (0.24 to 0.47)	0.36; (0.24 to 0.48)	0.41; (0.28 to 0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.96
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.004
	Confidence Interval	(2-Sided) 95%; -0.16 to 0.17
	Estimation Comments	Intravitreal - periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.51
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -0.11 to 0.23
	Estimation Comments	Dexamethasone - periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.54
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; -0.12 to 0.22
	Estimation Comments	Dexamethasone - intravitreal

7. Secondary Outcome

Title	Change in Best-corrected Visual Acuity at 8 Weeks
Description	Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Time Frame	Over 8 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Mean (95% Confidence Interval); Unit of Measure: Standard letters
	4.37; (1.86 to 6.89)	9.70; (7.26 to 12.13)	9.53; (7.01 to 12.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in mean change from BL
	Estimated Value	5.32
	Confidence Interval	(2-Sided) 95%; 1.82 to 8.82
	Estimation Comments	Intravitreal - periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in mean change from BL
	Estimated Value	5.16
	Confidence Interval	(2-Sided) 95%; 1.60 to 8.72
	Estimation Comments	Dexamethasone - periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.93
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in mean change from BL
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -3.67 to 3.34
	Estimation Comments	Dexamethasone - intravitreal

8. Secondary Outcome

Title	Change in Best-corrected Visual Acuity at 24 Weeks
Description	Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Time Frame	Over 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Mean (95% Confidence Interval); Unit of Measure: Standard letters
	4.07; (0.64 to 7.51)	9.60; (6.87 to 12.34)	9.21; (6.62 to 11.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.013
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in mean change from BL
	Estimated Value	5.53
	Confidence Interval	(2-Sided) 95%; 1.14 to 9.92
	Estimation Comments	Intravitreal - periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.019
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in mean change from BL
	Estimated Value	5.14
	Confidence Interval	(2-Sided) 95%; 0.84 to 9.44
	Estimation Comments	Dexamethasone - periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.84
	Comments	[Not Specified]
	Method	mixed effects model
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in mean change from BL
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -4.16 to 3.37
	Estimation Comments	Dexamethasone-intravitreal

9. Secondary Outcome

Title	Number of Eyes With Vitreous Hemorrhage
Description	Count of eyes with vitreous hemorrhage as an immediate complication of injection.
Time Frame	During 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Measure Type: Number; Unit of Measure: Eyes with uveitic macular edema
	1	0	1

10. Secondary Outcome

Title	Number of Eyes With Retinal Tear or Detachment
Description	Count of eyes with retinal tears or detachments during the course of follow-up.
Time Frame	During 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Measure Type: Number; Unit of Measure: Eyes with uveitic macular edema
	1	0	0

11. Secondary Outcome

Title	Number of Eyes With Endophthalmitis
Description	Count of eyes with an occurrence of endophthalmitis
Time Frame	During 24 weeks of folllow-ip

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	82	79
Measure Type: Number; Unit of Measure: Eyes with uveitic macular edema
	1	0	0

12. Secondary Outcome

Title	Cumulative Proportion of Eyes With Severe Vision Loss
Description	Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up.
Time Frame	During 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	81	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Cumulative proportion of eyes at 24 wks
	0.11; (0.04 to 0.18)	0.10; (0.0 to 0.22)	0.05; (0.0 to 0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.10
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; 0.09 to 1.24
	Estimation Comments	Intravitreal/Periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.20
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.46
	Confidence Interval	(2-Sided) 95%; 0.14 to 1.50
	Estimation Comments	Dexamethasone/Periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.62
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95%; 0.34 to 6.26
	Estimation Comments	Dexamethasone/Intravitreal

13. Secondary Outcome

Title	Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
Description	Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up.
Time Frame	During 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	81	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Cumulative proportion of eyes at 24 wks
	0.14; (0.05 to 0.22)	0.26; (0.13 to 0.38)	0.39; (0.20 to 0.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.11
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.92
	Confidence Interval	(2-Sided) 95%; 0.86 to 4.29
	Estimation Comments	Intravitreal/Periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.85
	Confidence Interval	(2-Sided) 95%; 1.30 to 6.28
	Estimation Comments	Dexamethasone/Intravitreal

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.30
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.43
	Confidence Interval	(2-Sided) 95%; 0.72 to 2.81
	Estimation Comments	Dexamethasone/intravitreal

14. Secondary Outcome

Title	Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
Description	Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up.
Time Frame	During 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

As randomized

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	81	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Cumulative proportion of eyes at 24 wks
	0.20; (0.09 to 0.29)	0.30; (0.17 to 0.40)	0.41; (0.26 to 0.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.09
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.83
	Confidence Interval	(2-Sided) 95%; 0.91 to 3.65
	Estimation Comments	Intravitreal/periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.52
	Confidence Interval	(2-Sided) 95%; 1.29 to 4.91
	Estimation Comments	Dexamethasone/periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.37
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; 0.72 to 2.43
	Estimation Comments	Dexamethasone/intravitreal

15. Secondary Outcome

Title	Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
Description	Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up.
Time Frame	During 24 weeks of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Periocular Triamcinolone 40mg	Intravitreal Triamcinolone 4mg	Dexamethasoneintravitreal Implant
Arm/Group Description:	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.	(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.	Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
Overall Number of Participants Analyzed	65	63	64
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes with uveitis macular edema	74	81	78
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Cumulative proportion of eyes at 24 wks
	0.06; (0.00 to 0.12)	0.06; (0.01 to 0.12)	0.04; (0.00 to 0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Intravitreal Triamcinolone 4mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.92
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.28 to 4.01
	Estimation Comments	Intravitreal/Periocular

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Periocular Triamcinolone 40mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.65
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95%; 0.16 to 3.11
	Estimation Comments	Dexamethasone/Periocular

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intravitreal Triamcinolone 4mg, Dexamethasoneintravitreal Implant
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.53
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.16 to 2.59
	Estimation Comments	Dexamthasone/Intravitreal

Adverse Events

Time Frame	24 weeks of follow-up
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Periocular Triamcinolone 40mg		Intravitreal Triamcinolone 4mg		Dexamethasoneintravitreal Implant
Arm/Group Description	Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Periocular triamcinolone 40 mg: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.		(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0 Second injection permitted at Week 8 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Intravitreal triamcinolone 4 mg: Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.		Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0 Second injection permitted at Week 12 IF: Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) OR eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield OR ME is worse after initial improvement;; IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents; Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
All-Cause Mortality
	Periocular Triamcinolone 40mg		Intravitreal Triamcinolone 4mg		Dexamethasoneintravitreal Implant
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/65 (0.00%)		0/63 (0.00%)		0/64 (0.00%)
Serious Adverse Events
	Periocular Triamcinolone 40mg		Intravitreal Triamcinolone 4mg		Dexamethasoneintravitreal Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/65 (9.23%)		5/63 (7.94%)		6/64 (9.38%)
Eye disorders
Choroidal * 1	0/65 (0.00%)	0	0/63 (0.00%)	0	1/64 (1.56%)	1
Ocular hypertension * 1	1/65 (1.54%)	1	0/63 (0.00%)	0	0/64 (0.00%)	0
uveitis * 1	0/65 (0.00%)	0	0/63 (0.00%)	0	1/64 (1.56%)	1
Vitreous haemorrhage * 1	0/65 (0.00%)	0	0/63 (0.00%)	0	1/64 (1.56%)	1
Gastrointestinal disorders
colitis * 1	1/65 (1.54%)	1	0/63 (0.00%)	0	0/64 (0.00%)	0
gastric polyps * 1	0/65 (0.00%)	0	0/63 (0.00%)	0	1/64 (1.56%)	1
General disorders
injection site injury * 1	1/65 (1.54%)	1	0/63 (0.00%)	0	0/64 (0.00%)	0
Infections and infestations
pneumonia * 1	0/65 (0.00%)	0	0/63 (0.00%)	0	1/64 (1.56%)	1
Investigations
Intraocular pressure increased * 1	0/65 (0.00%)	0	2/63 (3.17%)	2	0/64 (0.00%)	0
mediastinoscopy * 1	0/65 (0.00%)	0	1/63 (1.59%)	1	0/64 (0.00%)	0
Investigation * 1	1/65 (1.54%)	1	0/63 (0.00%)	0	0/64 (0.00%)	0
Musculoskeletal and connective tissue disorders
bursitis * 1	1/65 (1.54%)	2	0/63 (0.00%)	0	0/64 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease * 1	0/65 (0.00%)	0	1/63 (1.59%)	1	0/64 (0.00%)	0
pulmonary hypertension * 1	0/65 (0.00%)	0	1/63 (1.59%)	1	0/64 (0.00%)	0
Surgical and medical procedures
knee arthroplasty * 1	1/65 (1.54%)	1	0/63 (0.00%)	0	0/64 (0.00%)	0
shoulder arthroplasty * 1	0/65 (0.00%)	0	0/63 (0.00%)	0	1/64 (1.56%)	1
1 Term from vocabulary, MedDRA (18.1); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Periocular Triamcinolone 40mg		Intravitreal Triamcinolone 4mg		Dexamethasoneintravitreal Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0.00%)		0/63 (0.00%)		0/64 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Elizabeth Sugar, PhD
• Organization: Johns Hopkins University
• Phone: (410) 614-7837
• EMail: esugar2@jhu.edu

Publications of Results:

Thorne JE, Sugar EA, Holbrook JT, Burke AE, Altaweel MM, Vitale AT, Acharya NR, Kempen JH, Jabs DA; Multicenter Uveitis Steroid Treatment Trial Research Group. Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial. Ophthalmology. 2019 Feb;126(2):283-295. doi: 10.1016/j.ophtha.2018.08.021. Epub 2018 Sep 27.

• Responsible Party: JHSPH Center for Clinical Trials
• ClinicalTrials.gov Identifier: NCT02374060
• Other Study ID Numbers: IRB00006139; 1U10EY024527-01 ( U.S. NIH Grant/Contract )
• First Submitted: February 18, 2015
• First Posted: February 27, 2015
• Results First Submitted: August 28, 2018
• Results First Posted: November 5, 2018
• Last Update Posted: December 4, 2018